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First experiences with an ADR report clinical documentation tool

Date: 20 December 2017

As part of the WEB-RADR project, Lareb developed a tool (ClinDoc) to measure the level of clinical information in adverse drug reaction (ADR) reports. A unique aspect of this tool is that it first takes all clinical information into consideration that is important for a proper assessment of the ADR report. Subsequently, the availability of this information is assessed.

ClinDoc contains four domains: the ADR, chronology, suspected drug and patient characteristics. These domains include several subdomains. For example the domain patient characteristics contains subdomains about risk factors, concomitant medication, and patient’s life style. The tool should be used on a case-by-case basis and categorizes ADR reports into well, moderate or poor documentation of clinical information.

The first experiences with this tool are promising. It is a flexible model that takes the diversity of all types of ADRs and drugs into account. Results demonstrated that it is mainly sensitive for ADR reports with poorly reported clinical information.

For examples of how to use ClinDoc, see the User Instruction.

Reference : Oosterhuis I, Rolfes L, Ekhart C, Muller-Hansma A, Härmark L, First experiences with a tool to measure the level of clinical information present in adverse drug reaction reports, Expert Opin Drug Saf. 2017 Nov 20:1-5. ahead of print

Rolfes  L, van Hunsel F, van der Linden L, Taxis K, van Puijenbroek E. The Quality of Clinical Information in Adverse Drug Reaction Reports by Patients and Healthcare Professionals: A Retrospective Comparative Analysis. Drug Saf. 2017 Jul;40(7):607-614. doi: 10.1007/s40264-017-0530-5.

Funding: the development of the ClinDoc was part of the WEB-RADR project ( which is a public private partnership coordinated by the Medicines and Healthcare product Regulatory Agency, Grant Agreement n° 115632

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